Download Clever Choice Voice+ Owner`s manual

Blood Glucose Monitoring System
Owner’s manual
Version 3.0
July 2009
Dear CLEVER CHOICE Auto-Code Voice Blood Glucose Monitoring System Owner:
This manual contains important information you must know about the system. Please read it thoroughly and carefully.
The most innovative of this system is its speaking function, which is an
acoustic aid for users especially with visual disability. The system also provides One Code function which means that you don’t need to calibrate your
meter, making it easier for the user to monitor blood glucose at home.
2
IMPORTANT SAFTY INSTRUCTIONS
READ THIS BEFORE USING
The following basic safety precautions should always be taken.
1.Close supervision is necessary when the device is used by, on, or near
children, handicapped people or invalids.
2.Use the device only for the intended use described in this manual.
3.Do not use accessories which are not supplied by the manufacturer.
4.Do not let the equipment or its flexible cord come into contact with surfaces which are too hot to touch.
5.Do not use the equipment where aerosol sprays are being used, or
where oxygen is being administered.
6.Do not use the device if it is not working properly, or if it has suffered any
damage.
7.Before using the product to test your blood glucose, read all instructions
thoroughly and practice the test. Do all quality control checks as directed
and consult with a diabetes healthcare professional.
KEEP THESE INSTRUCTIONS
3
TABLE OF CONTENTS
IMPORTANT SAFETY INSTRUCTIONS
IMPORTANT INFORMATION
ABOUT ALTERNATIVE SITE TESTING (AST)
INSTRODUCTION OF THE SYSTEM
Intended Use
Principle of Measurement
Contents of the System
Appearance and Key Functions of the Meter
Meter Display Segments
Speaking Function
Appearance of the Test Strip
PREPARATION BEFORE USE
Battery Replacement
Setting the Meter and Deleting the Memory
BEFORE TESTING
Checking the Code Number
Checking with CLEVER CHOICE Control Solutions
Important Control Solution Test Information
Doing a Control Solution Test
TESTING YOUR BLOOD
Testing Procedure
Expected Test Results COMPARING METER AND LABORATORY RESULTS
USING THE METER MEMORY
Viewing Results on the Meter
Viewing Results on a Personal Computer
CARING FOR YOUR METER AND TEST STRIPS
Cleaning
Storage
4
03
06
07
09
09
09
10
11
12
13
14
15
15
17
21
21
22
23
24
27
28
34
35
36
36
39
40
40
40
PROBLEM-SOLVING GUIDE
Special Messages
Error Messages
Problem in operation
SPECIFICATIONS
SUMMARY OF OPERATION
43
44
45
46
48
49
5
IMPORTANT INFORMATION
Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult a
healthcare professional immediately.
If you get your blood glucose results lower or higher than usual, and do
not have symptoms, first repeat the test. If you have symptoms or continue to get results higher or lower than usual, follow the treatment advice
of your healthcare professional.
Apply only capillary whole blood sample to test your blood glucose.Applying other substances will cause wrong results.
If you are experiencing symptoms that are not consistent with your blood
glucose test results and you have followed all instructions described in
this owner’s manual, call your healthcare professional.
Inaccurate results may occur in severly hypotensive individuals or patients in shock.Inaccurate low results may occur for individuals experiencing a hyperglycemic-hyperosmolar state,with or without ketosis. Critically ill patients should not be tested with blood glucose meters.
Please refer to your test strip package insert for additional important
information.
6
ABOUT ALTERNATIVE SITE TESTING (AST)
Important: There are limitations for doing AST.
Please consult your healthcare professional before you do AST.
What is AST?
Alternative site testing (AST) means
that people use parts of the body other than fingertips to check their blood
glucose levels. This system allows
you to test on the palm, the forearm,
the upper arm, the calf, or the thigh
with the equivalent results to fingertip
testing.
What’s the advantage?
Fingertips feel pain more readily because they are full of nerve endings
(receptors). At other body sites, since
nerve endings are not so condensed,
you will not feel as much pain as on
the fingertip.
When to use AST?
Food, medication, illness, stress and exercise can affect blood glucose
levels. Capillary blood at fingertip reflects these changes faster than capillary blood at other sites. Therefore when testing blood glucose during or
immediately after meal, physical exercise, or any other event, take blood
sample from your finger only.
We strongly recommend you do AST ONLY in the following intervals:
In a pre-meal or fasting state (more than 2 hours since the last meal).
Two hours or more after taking insulin.
Two hours or more after exercising.
7
Do NOT use AST if:
You think your blood glucose is low.
You are unaware of hypoglycemia.
Your AST results do not match the way you feel.
You are testing for hyperglycemia.
Your routine glucose results are often fluctuating.
How to increase the accuracy?
Stimulating blood perfusion by rubbing the puncture site prior to blood extraction has a significant influence on the glucose value obtained. Blood
from the site without rubbing exhibits a measurably different glucose concentration than blood from the finger. When the puncture site is rubbed
prior to blood extraction, the difference is significantly reduced.
Please follow suggestions below before getting a drop of
blood:
Rub the puncture site about 20 seconds before penetration.
Use a clear cap instead while setting the lancing device.
8
INTRODUCTION OF THE SYSTEM
Intended Use
The system is intended for use outside the body (in vitro diagnostic use).
It should be used only for testing glucose (sugar) and only with fresh capillary whole blood (samples from the finger. the palm, the forearm, the upper
arm, the calf and the thigh.) The system is intended for use at home and in
clinical settings. It should not be used for the diagnosis of diabetes or for
the testing of newborns.
AST in this system can be used only during steady-state blood glucose
conditions described in the section of “About AST”.
This system contains a speaking functionality which provides step by step
instructions to aid visually impaired persons
Principle of Measurement
The test is based on the measurement of electrical current generated
by the reaction of glucose with the reagent of the strip. The meter measures the current and displays the corresponding blood glucose level. The
strength of the current produced by the reaction depends on the amount of
glucose in the blood sample.
9
Contents of the System
The system consists of three main products: the blood glucose meter, the
test strips, and a vial of control solution. These products have been designed, tested, and proven to work together as a system to produce accurate blood glucose test results. Use only CLEVER CHOICE Auto-Code
Voice test strips and CLEVER CHOICE control solution with the blood glucose meter.
Your system includes:
jA meter
Lancing device (optional)
kTest strips (optional)
Control solution (optional)
lSterile lancets Clear cap (optional)
mOwner’s manual
Log book
Warranty card
nSporty carrying case
oYour Quick reference guide
9F

NOTE
Please make sure that all products listed above are contained and
sealed in the package before using this system. If you find any imperfection in our products, please return the whole system to the place
of purchase.
Test strips, control solutions, lancets, lancing device and clear cap are
optional, and not included in the standard kit. Please ask the Customer Care Line at 1-877-342-2385 or place of purchase for availability.
10
Appearance and Key Function of the Meter
TEST SLOT
is where you insert the
test strip.
The meter will turn on
automatically after
insertion.
LCD DISPLAY
guides you through the
test using symbols and
simple messages.
CONTROL
SOLUTION BUTTON
located in front of the
meter with “C” on it,is
used to enter the
control solution testing
mode.
TALKING SYMBOL
indicates that the meter
contains speaking
function.
MAIN BUTTON
located in front of the
meter with "M" on the
meter, is used to turn
on the meter, enter the
memory mode and
control steps of setting.
BATTERY
BATTERY
SET
SET BUTTON
(in the back)
located in the battery
compartment, is
used to set up the
meter.
DATA PORT
located at the
side, is for cable
connection.
11
Meter Display Segments
TEST STRIP SYMBOL
Appears when the meter is
turned on.
VOICE SYMBOL
Indicates speaking function is on/off.
BLOOD DROP SYMBOL
Flashes when it is ready to apply the sample.
TEST RESULT AREA
Displays glucose results.
A decimal point appears
when the measurement unit
is mmol/L.
TEMPERATURE
SYMBOL
Appears when ambient
temperature is outside
operating temperature.
LOW BATTERY SYMBOL
Appears when the battery
is low.
LOW/HIGH SYMBOL
DATE
TIME
CTL SYMBOL
Appears when doing a control
test and indicates that the
result won’t be stored in the
memory.
DAY AVERAGE
Indicates that the displayed test
result is an average.
MEMORY SYMBOL
Appears when you review the
memory
12
MEASUREMENT UNIT
Appears with the test result
either in mg/dL or in mmol/L.
KETONE WARNING
Appears when the test result is
equal or higher than 240 mg/dL
(13.33 mmol/L).
Speaking Function
When a talking symbol [insert head symbol] is on the meter, it means that
the meter provides speaking function. It “speaks” step by step to lead you
to test your blood glucose in order. The following table tells you when and
what the meter “speaks”. Those messages can also be found in the end
section of this manual “SUMMARY OF OPERATION”.
WHEN
does the meter speak?
WHAT
does the meter speak?
A welcome music plays.
When turning the meter on
Thank you for using this product.
Please relax during measurement.
When room temperature
is outside operating range,
which is 50°F-104°F(10°C40ºC).
Room temperature out of range,
unable to measure.
When the meter is ready to
test. ( symbol appears on
display)
Please apply blood into the strip.
When the test is completed.
(The result appears on display)
The blood glucose is (number) milligram per deciliter/ millimole per liter
When the test result is
outside measurement range,
which is 20-600 mg/dL (1.133.3mmol/L)
The blood glucose out of range, unable to measure
When turning the meter is off
An ending music plays.
13
Appearance of the Test Strip
Your system measures the amount of sugar (glucose) in whole blood.
Blood is applied to the absorbent hole of the test strip and is automatically
drawn into the reaction cell where the reaction takes place.
The test strip consists of the following parts:
Contact Bars
Insert this end of the test strip into the meter.
Push it in firmly until it goes no further.
Test Strip Handle
Hold this part to insert the test strip into the slot.
Confirmation Window
This is where you confirm if enough blood has
been applied to the absorbent hole of the strip.
Absorbent Hole
Apply a drop of blood here,
The blood will be sucked automatically.
Please see pages 27-33, “Testing Your Blood”, for complete instructions.
14
PREPARATION BEFORE USE
Battery Replacement
Your meter comes with two 1.5V AAA alkaline batteries. The meter will alert
you when the power is getting low by displaying two different messages:
1.The symbol appears on LCD:the meter is functional, and the result remains
accurate, but it is time to change the
battery.
2. The symbol, low and E-b symbols
on LCD: the battery can not provide
enough power for a test. You must
change the battery immediately.
PLEASE NOTE
Replacing the battery does not affect the meter’s memory (previous test results stored in memory). However, the time and
date settings may need to be updated.
Batteries might leak chemicals if not used for a long time. Remove the battery if you are not going to use the device for an
extended period (i.e., 3 months or more)
Do not reuse battery. Use only new batteries of the specified
size and type.
15
To replace the battery, make sure that the meter is turned off.
STEP1 Press the buckle on battery
cover and lift up to remove
cover.
STEP2 Remove the old batteries and
replace with two 1.5V AAA
alkaline batteries.
STEP3 Close the battery cover.
WARNING
As with all small batteries, the batteries should be kept away from
small children who still put things in their mouths. If they are swallowed any objects,, promptly seek medical help.
16
Setting the Meter and Deleting the Memory
Your meter comes with the time, date, and unit of measurement preset.
However, if you need to set these parameters, or if you are replacing the
batteries, you may need to enter the setting mode and reset.
Please set the time, date, unit of measurement , delete memory, select language or select speaking function according to the ffollowing
steps.
To set the time, you must first enter the setting mode. Start with the meter
off; then press the set button located in the battery compartment. The meter is now in the setting mode.
STEP 1 Set the Year
The year appears first, with the number
flashing. Press and release the M button to
advance one year. To move faster, hold the
M button down. With the correct year on the
display, press the set button and the date
will appear on the display with the month
segment flashing.
STEP 2 Set the Month
Press and release the M button until the correct month appears. To move faster, hold
the M button down. With the correct month
on the display , press the set button and the
day segment will start flashing.
STEP 3 Set the Day
Press and release the M button until the correct day appears. To move faster, hold the
M button down. With the correct day on the
display, press the set button and the time will
appear on the display with the hour segment
flashing.
17
STEP 4 Set the Hour
Press and release the M button to advance
one hour. To move faster, hold the M button
down. With the correct hour on the display,
press the set button and the minutes setting
will start flashing.
STEP 5 Set the Minutes
Press and release the M button to advance
one minute. To move faster, hold the M button
down. With the correct minute on the display,
press the set button and the current unit of
measurement will start flashing.
STEP 6 Select mg/dL or mmol/L
Press and release the M button to select the
unit of measurement you want to use.
18
STEP 7 Delete memory
“dEL” and flashing “
” symbol appear on LCD. If you do not want to
delete the memory, press the set button again to skip this step. If you’d
like to delete ALL the memory, press M button, both “dEL” and “
” will
flash. Press the M button again to delete ALL the memory. The meter then
displays ”
”, which means that the memory is deleted.
Press the set button to proceed to the next step.
NOTE
The time and date can ONLY be changed in the setting mode. Therefore, when you perform a glucose testing, those parameters are not
possible to be changed.
Your meter displays 7-, 14-, 21-, 28-, 60- and 90-day averages which
you can access from the meter memory. These averages are calculated from results obtained during the 7-, 14-, 21-, 28-, 60-and
90-days preceding the current date and time settings. When the date
and time are changed, the 7-, 14-, 21-, 28-, 60- and 90-day averages
may change.
While the meter is in the setting mode, if no button is pressed for 3
minutes, the meter will turn off automatically.
19
STEP 8 Select speaking function
The meter displays “VOL”, “ ” and flashing
number. Press M button to select speaking
volume from 0 to 7; then press the set .
Number 0 indicates that the speaking function is turned off, which “ ” is not displayed
on LCD during testing. Number 1 to 7 indicates speaking volume from low to high,
which “
” is displayed on LCD during testing.
STEP 9 Select language
L1/L2 and “
” display on LCD. Press the
M button to select. Can select from two languages. Press set button to switch between
L1 for English and L2 for Spanish. Once you
have selected your desired language press
M button to set the language.
Set-up is all completed. Press the set button to turn off the meter. “OFF” is displayed
before shutting down.
Congratulations! You have finished all settings now!
20
BEFORE TESTING
Checking the Code Number
This system provides you One Code function. You do not have to calibrate the meter when you use a new vial of test strips. You just need to
make sure that the code number on the test strip vial is “9F” before you
proceed.
Please note that CLEVER CHOICE Auto-Code Voice system only works
with “9F” code number. If the code number on the test strip vial is not
“9F”, please stop testing and contact your local agent for help. Failure to
do so will get the wrong result.
9F
21
Checking with CLEVER CHOICE Control Solution
CLEVER CHOICE Control Solution contain a known amount of glucose
that reacts with test strips. By comparing your control solution test results
with the expected range printed on the test strip vial label, you are able to
check that the meter and the test strips are working together as a system
and that you are performing the test correctly. It is very important that you
do this simple check routinely to make sure you get accurate results.
How often should the control solution test be performed?
When you use this system to test your blood for the first time, practice the
procedure using control solution. When you can do three tests in a row
with results within the expected range, you are ready to test your blood.
To routinely check the meter and test strips, perform a single test for each
level of control solution at least once a week.
When should the control solution test be performed?
When you first get your Glucose Meter.
When you begin using a new vial of test strips.
Whenever you suspect that the meter or test strips are not working properly.
When your blood glucose test results are not consistent with how you
feel, or when you think your results are inaccurate.
When your test strips are exposed to extreme environmental conditions.
(See Important Test Strip Information section of this manual)
When you want to practice running the test.
When you drop the meter.
22
Important Control Solution Test Information
Use only CLEVER CHOICE control solutions. Check the expiration date
on the control solution vial. Do not use if expired.
Control solution, meter, and test strips should come to room temperature
(68-77°F/20-25°C) before testing.
Shake the vial before use. Discard the first drop of control solution after
squeezing, and wipe off the dispenser tip to ensure a good sample and
an accurate result.
Use a only for 90 days after first opening. Record the discard date (date
opened plus 90 days) on the control solution vial. Discard after 90
days.
Store the control solution tightly closed at temperatures 36-86°F (2-30°C).
Do not freeze.
NOTE
The control solution range printed on the test strip vial is for
CLEVER CHOICE control solution only. It is used to test meter
and test strip performance. It is not the recommended range for
your blood glucose level.
23
Doing a Control Solution Test
STEP 1 Insert Test Strip
Insert a test strip with contact bars end first
and blue side of strip facing up into the test
slot. The meter turns on automatically and
displays “CH”, and “
” then the code
number, and lastly a flashing symbol.
STEP 2 Press the C button
After the symbol appears on display, press
the C button and then “CTL” appears on the
display. With the “CTL” sign on the display,
the meter will not store your test result in
memory. If you decide not to perform a control solution test, press the C button again
and the “CTL” sign will disappear.
NOTE
Contact bars must be inserted all the way into meter or you may
get an inaccurate test result.
Every time you perform a control solution test, you must enter
the “CTL” test mode so that the test result will not be stored in
the meter memory. Failure to do so will confuse the blood glucose test result with the control solution test result in memory.
24
STEP 3 Obtain Control Solution
Shake the control solution vial well.
Remove the cap, squeeze the vial,
discard the first drop, and wipe off the
dispenser tip to prevent contamination.
Squeeze the vial again to get another
drop and place the drop on the top of the
cap.
STEP 4 Apply Control Solution
While holding the meter, move the absorbent hole of the test strip to touch the
drop of control solution. Then the drop
will be automatically drawn into the test
strip. Make sure the confirmation window
is completely filled. The meter begins to
count down.
To avoid contaminating the control solution with the content of the test strip, you
have to place a drop of control solution
on a clean surface. Do not directly apply
control solution into a strip.
CAUTION
To avoid contaminating the control solution with the content of the
test strip, you have to place a drop of control solution on a clean
surface or on your finger tip first. Do not directly apply control
solution into a strip.
25
STEP 5 A Result Appears in 7 Seconds.
After counting down to 0, the control solution test result appears. Compare
the result with the range printed on the test strip vial. The result should fall
within this range.
Normal
102~154
Out-of-range results
If test results fall outside the range printed on the test strip vial, check the
section of “Problem in Operation” in troubleshooting guide and repeat the
test. If you continue to get out-of-range results, it means that the system
may not be working properly. Do NOT test your blood. Contact the Customer Care Line at 1-877-342-2385 for help.
26
TESTING YOUR BLOOD
Be sure to read this section and the test strip package insert found in the
test strip box carefully before testing. Make sure you have all items needed
to test:
A.Blood Glucose Meter
B.Test Strip
C.Lancing Device
D.Pharmacist Choice Brand Lancets
E.Clear Cap (For AST use)
A.
B.
C.
D.
E.
WARNING
To reduce the chance of infection:
Never share a lancet or the lancing device with others.
Always use a new, sterile lancet. Lancets are for single use
only.
Avoid getting hand lotion, oils, dirt, or debris in or on the lancets
and the lancing device.
27
Testing Procedure
Wash and dry your hands first before starting.
STEP 1 Insert a Lancet in the Adjustable Lancing Device.
Screw off the cap of the lancing device.
Insert a lancet into the lancet holder and
push down firmly until it is fully seated.
Twist the protective disk until it separates
from the lancet.
Replace the lancing device cap. Turn the
Cap until it is snug but not too tigh
The adjustable tip offers 5 levels of skin
penetration. Twist the adjustable tip in
either direction until the number lines up
with the Arrow:
1-2 for soft or thin skin, 3 for average skin,
4-5 for thick or calloused skin.
28
Slide the ejection/cocking control
back until it clicks. If it does not
click, the device may have been
cocked when the lancet was inserted.
Blood from sites other
than the fingertip
A clear cap, together with the kit,
makes it easier to get a drop of
blood for AST. When you want to
obtain blood from sites other than
the finger, replace the lancet device cap with the clear cap.
Turn the clear cap until it is snug
but not too tight, and then slide the
ejection/cocking control back until it clicks.
The lancing device is now ready for use. Set aside for later use.
29
STEP 2 Insert Test Strip
Insert a test strip into the test slot, with contact bars end
first and blue side of strip facing up. The meter turns on
automatically and displays the followings in sequence:
“CH”, and “
” then the code number and lastly a
flashing symbol.
STEP 3 Get a Drop of Blood
Select the puncture site either in finger or in other parts (AST). Clean the
puncture site with 70% alcohol cotton and let it air-dry.
30
Fingertip
Hold the Lancing Device firmly against
the side of your finger. Press the release button. You will hear a click, indicating that the puncture is complete.
Sites other than fingertip
Please refer to the section of “About
AST.”f or available punctured sites.
After penetration, discard the first drop
of blood with a clean tissue paper or
cotton. Then gently squeeze the punctured area to obtain blood. But be
attentive NOT to smear the blood
sample. The volume of blood sample
must be at least 0.7 microliter ( actual
size).
PLEASE NOTE
Choose a different spot each time you test. Repeated punctures in the same spot may cause soreness and calluses.
Before you decide to do Alternate site testing, please consult
your health care provider.
Since the first drop of blood usually contains tissue fluid and
serum,which may affect the test result, it is recommended to
be discarded.
31
STEP 4 Apply blood into the test strip
When “ “ is flashing on the screen, apply your
blood to the absorbent hole of the test strip until the confirmation window is fully filled with
blood. The meter then begins to count down
automatically.
STEP 5 Obtain an Accurate Result in
7 Seconds.
The result of your blood glucose test is shown
after the meter counts down to 0. This reading
is automatically stored in the meter.
PLEASE NOTE
Do not push your finger (with blood on it) against the test strips;
or try to apply a smeared sample on the test strip.
If you do not apply a blood sample to the test strip within 3 minutes, the meter will automatically turn off. You must remove and
reinsert the test strip to restart the test procedure.
The blood should completely fill the confirmation window before
the meter begins to count down. If you find that the confirmation window is not filled with blood when the meter is counting,
NEVER try to add more blood to the test strip. Discard the
test strip and retest with a new one.
If you have trouble filling the test strip, please contact the Customer Care Line at 1-877-342-2385 for help.
32
STEP 6 Remove the Lancet
Always use caution when removing the lancet.
Take the lancet out carefully. Place the disk on a
hard surface and push the exposed tip into the protective disk.
WARNING
The used lancet and the used test strip may be potentially biohazard. Please discard them carefully according to your
healthcare provider’s instructions.
33
Expected Test Results
Blood glucose monitoring plays an important role in diabetes control. A
llong-term study shows that keeping blood glucose levels close to
normal can reduce the risk of diabetes complications by up to 60%*3.
The results you get with the CLEVER CHOICE Auto-Code Voice Blood
Glucose Monitoring System can help you and your healthcare professional
monitor and adjust your treatment plan to gain better control of your diabetes.
Time of day
Plasma glucose range (mg/
dL) for people without diabetes
Fasting and before
meal*4
70-130g/dL
2 hours after
meals*4
Less than 180mg/dL
Your target
range (mg/dL)
(3.9-7.2 mmol/L)
(10 mmol/L)
*3: American Diabetes Association position statement on the Diabetes Control and
Complications Trial (1993).
*4: American Diabetes Association (2008). Standards of Medical Care in Diabetes.
Diabetes Care, 31 (Supplement 1): S12–S54.
Please work with your doctor to determine a target range that works best for you.
34
COMPARING METER AND LABORATORY RESULTS
The meter provides you with whole blood equivalent results. The result you
obtain from your meter may differ somewhat from your laboratory result due to
normal variations. Meter results can be affected by factors and conditions that
do not affect laboratory results in the same way (See test strip package insert
for typical accuracy and precision data, and for important information on Limitations). To make an accurate comparison between meter and laboratory results,
follow the guide-lines below.
Before you go to the lab:
► Perform a control solution test to make sure that the meter is working properly.
► It is best to fast for at least eight hours before doing comparison tests.
► Take your meter with you to the lab.
While at the lab:
Make sure that the samples for both tests (the meter test and the lab test are
taken and tested within 15 minutes of each other).
► Wash your hands before obtaining a blood sample.
► Never use your meter with blood that has been collected in a gray-top test
tube.
► Use fresh capillary blood only.
You may still have a variation from the result because blood glucose levels can
change significantly over short periods, especially if you have recently eaten ,
exercised, taken medication, or experienced stress*6. In addition, if you have
eaten recently, the blood glucose level from a finger stick can be up to 70 mg/
dL (3.9 mmol/L) higher than blood drawn from a vein (venous sample) used for
a lab test*7. Therefore, it is best to fast for eight hours before doing comparison
tests. Factors such as the amount of red blood cells in the blood (a high or low
hematocrit) or the loss of body fluid (severe dehydration) may also cause a
meter result to be different from a laboratory result.
References
*6: Surwit, R.S., and Feinglos, M.N.: Diabetes Forecast (1988), April, 49-51.
*7: Sacks, D.B.: “Carbohydrates. “ Burtis, C.A., and Ashwood, E.R.( ed.), Tietz Textbook of Clinical Chemistry. Philadelphia: W.B. Saunders Company (1994), 959.
35
USING THE METER MEMORY
View Results on the Meter
Your meter stores the 450 most recent blood glucose test results with
date and time in its memory. It also provides you with 7-, 14-, 21-, 28-, 60and 90-day averages of your blood glucose test results. You can review
the test results in memory with these easy steps.
► Recall Test Results
With the meter turned off, press the M button twice, the most recent test
result with date and time will be shown. Press the M button once and the
next most recent test result will appear. Each time you press and release
the M button, the meter will recall up to your last 450 test results in order.
When the memory is full, the earliest result is dropped as the new data is
added.
When reaching the last set of result, “End” will be shown on LCD display,
and the meter will be turned off automatically.
36
► Enter the Memory Average Mode
With the meter turned off, press and hold the M button until
appears, then release the M button. The
7-day average will appear, indicating that you are in
the memory mode. If you continue to press the M
button, the 14-, 21-, 28-, 60- and 90- day average
will appear in order. After 90- day average appears,
“End”, “
” and “ ” will display, and the meter will
be turned off automatically.
When using the meter for the first time, “---“ appears,
showing that there are no test results in memory.
The 7- day average is calculated from the blood glucose results obtained during the last 7 days.
It also indicates how many blood glucose tests have
been performed within this period, e.g., 14 (14 tests
in the last 7 days).
The 14- day average is calculated from the blood
glucose results obtained during the last 14 days. It
also indicates how many blood glucose tests have
been performed, e.g.28 (28 tests in the last 14
days).
It’s all the same to the 21-, 28-, 60- and 90- day
average.
► Exit The Memory Mode
Keep pressing the M button for 5 seconds
to turn off the meter.
37
NOTE
The control solution results are NOT stored in the memory
(please also refer to NOTE on page 24 for information). The
list of past results and the result average are for blood glucose
results only.
When pressing the M button to recall the test results, the meter
will display date, time and the unit of measurement first. If you
do not press the M button within 5 seconds, the blinking “
”
and “↓”will appear. In the meantime, you can choose to insert
a test strip to start testing your blood or press the M button
again to review the stored test results.
If no button is pressed for 3 minutes, the meter will show “OFF”
and turn off automatically.
38
Viewing Results on a Personal Computer
Results in memory can be transmitted to a personal computer. Health
Care Software System and an interface cable are required for transmitting results to a personal computer. The software can be downloaded at
Taidocs’s website (http://www.taidoc.com). The interface cable is an optional accessory. To learn more about Diabetes Management Software or
to obtain an Interface Cable separately, please contact your local customer
service.
Step 1 Install Software
Download Health Care System Software and instructions manual at Taidoc’s website (http://www.taidoc.com). Install the software on your personal
computer.
Step 2 Connect to Personal Computer
Connect the interface cable to a serial port on your computer. With the
meter turned off, connect the Interface Cable to the data port of the meter.
“PC” will appear on the display, indicating that the meter is ready to transmit data.
Step 3 Transmit Data
Follow the instruction manual to transmit data from the meter’s memory to
your computer. Results transmitted will include date and time. Remove the
cable and the meter will automatically turn off.
NOTE
While the monitor is connected to the PC, it is unable to perform
a blood glucose test.
The meter may be affected by static electricity interference. If this
situation happened, please turn off the transmission function and
wait a few minutes to start this function.
39
CARING FOR YOUR METER AND TEST STRIPS
To avoid the meter and test strips getting dirt, dust or other contaminants, please wash and dry your hands thoroughly before use.
Cleaning
1. To clean the meter’s exterior, wipe with a cloth moistened with tap water
or a mild cleaning agent, then dry the device with a soft and dry cloth. Do
not flush with water.
2. Do not use organic solvents to clean the meter.
Storage
1. Meter Storage
Storage condition: - 4°F~140°F
(-20°C~60°C), below 95% relative humidity.
Always store or transport the meter in its
original storage case.
Avoid dropping and strong impact.
Avoid direct sunlight and humidity.
40
2. Strip Storage
Storage condition: 39.2°F~104°F
(4°C~40°C), below 85% relative humidity. Do not freeze.
Store your test strips in their original vial
only. Do not transfer to other container.
Store test strip packages in a cool and
dry place. Keep away from direct sunlight and heat.
After removing a test strip from the vial,
immediately replace the vial cap and
close it tightly.
Touch the test strip with clean and dry
hands.
Use each test strip immediately after
removing it from the vial.
Write the discard date (the date opened
plus 90 days) on the vial label when
you first open it. Discard remaining test
strips 90 days after first opening date.
Do not bend, cut, or alter a test strip in
any way.
Keep the strip vial away from children
since the cap and the test strip may
be a choking hazard. If swallowed,
promptly seek medical help.
41
3. Control solution storage
Storage condition: Store the control
solution tightly closed at temperatures
36-86°F (2-30°C). Do not freeze.
Record the discard date (date opened
plus 90 days) on the control solution
vial. Discard after 90 days.
42
PROBLEM-SOLVING GUIDE
Following is a summary of some display messages. These messages help
to identify certain problems but do not appear in all cases when a problem
has occurred. Improper use may cause an inaccurate result without producing an error message. In the event of a problem, refer to the information
under action.
Never try to disassemble the meter in any circumstances. If you encounter any error messages not listed below or if you have followed
the actions recommended below, but the problem keeps unsolved,
please call the Customer Care Line at 1-877-342-2385 for help.
43
Special Messages
MESSAGE
WHAT IT MEANS
ACTION
This indicates hypoglycemia (low blood glucose.)
Appears when your result
is below measurement limit,
which is less than 20 mg/dL You should immediately
(1.1 mmol/L).
treat hypoglycemia as
recommended by your
healthcare professional.
This indicates severe
hyperglycemia (high blood
Appears when your result is
glucose).
above measurement limit,
which is higher than 600
mg/dL (33.3 mmol/L).
You should seek immediate
medical assistance.
KETONE? appears when
your result is equal or
higher than 240 mg/dL(13.3
mmol/L).
44
This indicates there is a
possibility of ketone accumulation if you are Type
1 diabetes.
Please seek immediate
medical assistance.
Error Message
Message
What it means
Action
Appears when the battery can
not provide enough power for Replace the battery immediately.
a test.
Appears when inserting a used Test with a new test strip.
test strip.
Appears when environmental
temperature is below system
operation range.
System operation range is 50°F to 104°F
(10°C to 40°C). Repeat the test after the
meter and test strip have reached the
above temperature.
Appears when environmental
temperature is above system
operation range.
Remove the strip after applying Re-test with a new test strip.
blood to the absorbent hole.
Problem with calibration.
Check if the code number on the meter display matches the code number on the test
strip vial and re-test.
Problem with the meter.
Review the instructions and re-test with
a new test strip. If the problem is still unsolved, please call the Customer Care Line
at 1-877-342-2385 for help.
45
Problem in operation
1. If the meter does not display a message after inserting
a test strip:
PROBABLE CAUSE
Battery exhausted.
WHAT TO DO
Replace the battery.
Battery incorrectly installed or ab- Check that the battery is correctly
sent.
installed.
Test strip inserted upside down or Insert the test strip correctly with
incompletely.
the contact bars end.
Defective meter.
Please call the Customer Care Line
at 1-877-342-2385 for help.
2. If the test does not start after applying the sample:
PROBABLE CAUSE
WHAT TO DO
Insufficient blood sample.
Repeat the test using a new test strip
with larger volume of blood sample.
Defective test strip.
Repeat the test with a new test strip.
Sample applied after automati- Repeat the test with a new test strip.
cally shutoff (3 minutes after
Apply sample only when “ “appears
last user action).
on the display.
Defective meter.
46
Please call the Customer Care Line
at 1-877-342-2385 for help.
3. If the control solution test result is out of range.
POSSIBLE CAUSE
WHAT TO DO
Error in performing the test.
Read the instruction thoroughly and
repeat the test again.
Improper code number.
Check if the code number on the
display matches the code number on
the test strip vial.
Do not shake the control
solution vial very well.
Shake the control solution vigorously
and repeat the test.
Expired or contaminated
control solution.
Check the expiry date or the discarded date of the control solution.
Control solution that is too
warm or too cold.
Control solution, monitor, and test
strips should come to room temperature (68-77°F/20-25°C) before
testing.
Test strip deterioration.
Repeat the test with a new test strip.
Meter malfunction.
Contact the Customer Care Line at
1-877-342-2385 for help.
47
SPECIFICATIONS
Model No.: TD-4243
Dimension & Weight: 95.3mm(L) x 47.5mm(W) x 18.5mm(H), 70.02 g
Power source: two 1.5V AAA alkaline batteries
Display: Large LCD
Memory: 450 measurement results with date and time
Auto electrode inserting detection
Auto sample loading detection
Auto reaction time count-down
Auto turn-off after 3 minutes without action
Temperature warning
Operating condition: 50°F-104°F(10°C~40°C), below 85% R.H. (noncondensing)
Storage/Transportation condition: - 4°F~140°F (-20°C~60°C), below 95% R.H.
Measurement Units: mg/dL or mmol/L
Measurement Range: 20~600 mg/dL (1.1~33.3mmol/L)
The device has been certified to meet the electrical and safety requirements of:
IEC/EN 61010-1, IEC/EN 61010-2-101, EN 61326.
Distributor
Simple Diagnostics
PO box 128 Williston Park, NY 11596 USA
Customer Care Line:
1-877-342-2385
24-Hour TOLL-FREE-TELEPHONE ASSISTANCE
48
SUMMARY OF OPERATION
This summary is intended only for quick reference and not as a substitute
for the owner’s manual. Please read the entire manual before you begin
testing.
STEP 1. Insert test strip.
The meter is automatically turned on and
displays “CH” and “
”, follows by the
code number, and lastly a flashing symbol.
What
speaks?
Thank you for using this product.
STEP 2. Match the code
Check if LCD displayed code number is
same as the number on strip vial
What
speaks?
The code number is 9F.
9F
49
STEP 3. Apply sample
Touch and hold the drop of blood onto the
absorbent hole of test strip until confirmation window is completely filled.
What
speaks?
Please apply blood into the strip.
STEP 4. Obtain accurate results
in 7 seconds
The meter begins to count down. At the
time, if you find confirmation window does
not fill completely, do not add blood to the
strip. Discard the strip and use the new
one to retest.
What
speaks?
The blood glucose is 68 milligrams
per deciliter
STEP 5 Remove the Lancet
Always use caution when removing
the lancet.
Discard the used strip and the lancet
according to your healthcare provider’s
instructions.
50
NOTE
51
NOTE
52